Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well tolerated, and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults. The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied. The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment:

29

Study Completion Date:

July 2005

Detailed Description:

Combination regimens of RTV and IDV in adults offer the benefit of two potent antiretroviral agents, convenience of twice-daily dosing, unrestricted timing of meals, and fewer renal complications. There are limited, largely anecdotal data from children suggesting that initial virologic response can also be attained in children given IDV with RTV, but there are not sufficient pharmacokinetic data to define appropriate dose regimens. This study will evaluate the clinical feasibility of a combination RTV and IDV regimen for children.

Patients will be stratified on the basis of age/Tanner stage and ability to swallow intact capsules. Patients will be randomized to either Balanced Dose or Low Dose RTV treatment arms. Patients in the Balanced Dose Arm will receive RTV and IDV in approximately equal doses. The Low Dose RTV Arm will receive a dosing ratio of RTV:IDV of approximately 1:3. Patients will have scheduled study visits every 4 weeks for 6 months, then every 3 months for approximately 18 months. Study visits will consist of a medical history, physical exam, and blood and urine tests. Patients will have intensive pharmacokinetic analysis at Week 4 (or 2 weeks after a stable dose of study drugs has been reached) and Week 16. Study visits that include pharmacokinetic analysis will last 9 to 13 hours.

At each study visit, patients will be closely assessed for drug toxicity and virologic response. At the end of the study, patients with good virologic response and no evidence of toxicity may choose to enter a 48 week extension phase and continue taking the combination regimen.

Eligibility

Ages Eligible for Study:

2 Years to 17 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

HIV infection

HIV RNA levels > 10,000 copies/ml within 30 days prior to study entry

Anti-HIV drug therapy failure while on the same anti-HIV drugs for more than 16 weeks

Body size above a certain limit (body surface area > 0.48 m2)

Acceptable methods of contraception

Consent of parent or legal guardian

Exclusion Criteria

Unable to determine HIV genotypic resistance

HIV resistant to IDV or RTV at study screening

Previously received IDV and RTV at the same time

Need treatment with any medication prohibited by the study

Glucocorticoids for more than 14 days at study entry

Cancer requiring chemotherapy

Drugs affecting the immune system, other than IVIG, within 3 months of study entry

Certain abnormal laboratory results at study entry

Pregnant or breast-feeding

Unable to be followed at a PACTG center during the trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012519

Locations

United States, District of Columbia

Howard Univ. Washington DC NICHD CRS

Washington, District of Columbia, United States, 20060

United States, Florida

Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy